Table 1

Baseline characteristics (safety population)

TestosteronePlaceboTotal
n108112220
Age (years)59.9 ± 9.1 (37−77)59.9 ± 9.4 (39−88)59.9 ± 9.3 (37−88)
Race
 Caucasian105 (97)110 (98)215 (98)
 Asian3 (3)03 (1)
 Afro-Caribbean01 (1)1 (0.5)
 Other01 (1)1 (0.5)
Total serum testosterone (nmol/L)9.2 ± 2.6 (3.8−20.1)9.5 ± 3.3 (2.2−20.6)9.4 ± 3.0 (2.2−20.6)
Free testosterone (pmol)198.0 ± 49.3 (42−319)202.4 ± 62.1 (35−364)200.3 ± 56.1 (35−364)
Type 2 diabetes68 (6)69 (62)137 (62)
MetS88 (82)88 (79)176 (80)
Insulin resistance (HOMA-IR index)5.9 ± 3.8 (1−20)4.9 ± 3.3 (1−21)5.4 ± 3.6 (1−21)
Hematocrit (L/L)0.43 ± 0.04 (0.34−0.54)0.43 ± 0.04 (0.33−0.51)0.43 ± 0.04 (0.33−0.54)
Hemoglobin (g/dL)14.9 ± 1.5 (11.0−18.6)14.9 ± 1.3 (11.4−18.0)14.9 ± 1.4 (11.0−18.6)
PSA (μg/L)1.6 ± 1.8 (0.21−13.60)1.2 ± 1.2 (0.20−6.38)1.4 ± 1.5 (0.20−13.60)
FSH* (IU/L)12.3 ± 13.4 (1.2−63.6)12.5 ± 15.7 (1.2−78.9)12.4 ± 14.5 (1.2−78.9)
FSH*
 Low000
 Normal77 (71)79 (71)156 (71)
 High31 (29)33 (29)64 (29)
LH* (IU/L)5.7 ± 5.7 (0.9−34.3)5.3 ± 5.4 (0.6−36.1)5.5 ± 5.5 (0.6−36.1)
LH*
 Low02 (2)2 (1)
 Normal86 (80)92 (82)178 (81)
 High22 (20)18 (16)40 (18)
  • Data are mean ± SD (range) or n (%) unless otherwise indicated. FSH, follicle stimulating hormone; LH, luteinizing hormone.

  • *Screening values (not measured at baseline). Normal ranges: 0.7 IU/L ≤ FSH ≤ 11.1 IU/L; 0.8 IU/L ≤ LH ≤ 7.6 IU/L.